Role of the Microbiota in the Evolution of the SARS-CoV-2 Disease,COVID-19, in Hospitalized Patients

NCT04669938 | Unknown

• 1 other identifier: APHP201083
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients hospitalized for COVID-19 may need intensive care (e.g. mechanical ventilation) during hospitalization. Some risk factors are already known but better targeting of such patients is still needed, at least because existing risk factors are not strong enough to provide an accurate prediction. Care organization would benefit for such a predictive tool. Oropharyngeal and gut microbiota could potentially fill a significant gap in predictive performances. The investigators therefore propose to sample 200 patients (oropharyngeal and rectal swab) admitted in infectious disease department at Bichat Hospital and at high risk of needing intensive care during hospitalization. The investigators plan to perform metagenomic sequencing and bioinformatic analysis of these samples to characterize the diversity of bacterial species present in the oropharynx and the gut and to identify new factors associated with the need for intensive care. Aside metagenomic analyses, The investigators will perform semi-quantitative cultures of the oropharyngeal and gut microbiota to identify and quantify pathogens in order to predict the risk of bacterial infections in COVD-19 patients. For patients transferred in intensive care unit, The investigators will to perform another series of samples to better characterize the evolution of microbiota during mechanical ventilation and identify factors associated with the risk of developing a ventilator-associated pneumonia. Microbiota data will be considered together with the host genotype, the viral sequence and a deep immunological profiling to identify the main determinants of the evolution toward severity of COVID-19.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Identify risk factors associated with severe forms of COVID-19 requiring transfer to ICU

  The main endpoint is the indication of worsening of the general condition requiring transfer to ICU

  day 14

Secondary Outcomes (2)

• Link between the composition of the gut microbiota and admission to intensive care

  3 months

• Predictive performance of semi-quantitative culture and rapid metagenomic evaluation

  3 months

Study Arms (1)

Patients hospitalized for COVID-19

Other: oropharyngeal and intestinal microbiota; Other: host genotype; Other: host immune factors; Other: viral sequence

Interventions

oropharyngeal and intestinal microbiota OTHER

analysis of oropharyngeal and intestinal microbiota

Patients hospitalized for COVID-19

host genotype OTHER

analysis of a part of host genotype

Patients hospitalized for COVID-19

host immune factors OTHER

analysis of host immune factors

Patients hospitalized for COVID-19

viral sequence OTHER

analysis of viral sequence

Patients hospitalized for COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient with documented SARS-CoV-2 infection requiring hospitalization.

You may qualify if:

• Adult patient with documented SARS-CoV-2 infection requiring hospitalization.

You may not qualify if:

• Lack of consent
• Patients hospitalized in an intensive care unit
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

LESCURE

Paris, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Gastrointestinal Microbiome; Viral Packaging Sequence

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Microbiota; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Regulatory Sequences, Nucleic Acid; Base Sequence; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Nucleotide Motifs; Genetic Structures; Genetic Phenomena

Central Study Contacts

Etienne Ruppé

CONTACT

1 40 25 80 00; etienne.ruppe@aphp.fr

Xavier Lescure

CONTACT

1 40 25 80 00; xavier.lescure@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 17, 2020
• Study Start: December 4, 2020
• Primary Completion: December 4, 2021
• Study Completion: August 31, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-03

Locations

FR (1)